Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable /Metastatic Solid Tumors Who are Refractory to Available Standard Therapies

This study, called a Phase I-II trial, is looking at a new treatment named SKB264. It’s for adults whose advanced solid tumours (like certain cancers) have continued to grow despite having standard treatments. The main goals are to find out how safe SKB264 is, what different doses do, and if it can shrink tumours. Researchers will also check for any side effects, how long the treatment's effects last, and the overall health of participants. This is an early-stage study, meaning it’s one of the first times this medicine is being tested in people to see if it could be a helpful option in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.

Enrolment target

Start

17 Jun 2024

Metastatic or locally advanced unresectable solid tumors progressing after available standard therapies

What is this study about?

This study is a clinical trial, which is an important step in developing new medicines. It’s for people who have solid tumours that are advanced, meaning they have spread in the body or can't be removed by surgery. Crucially, these tumours must have continued to grow even after patients have tried the usual available treatments.

The new medicine being tested is called SKB264. This trial is a 'Phase I-II' study. Phase I focuses on safety, finding the right dose, and understanding how the medicine moves through the body. Phase II then looks more closely at whether the medicine actually works to treat the disease. So, in this study, doctors want to see if SKB264 can make tumours shrink or stop growing, and what side effects it might cause.

Researchers will be looking at several things. The main goal is to see how many patients experience their tumours shrinking or disappearing completely. They will also keep a close eye on any side effects, how long patients benefit from the treatment, and their overall survival. They will also study how the medicine behaves in the body and how it interacts with specific proteins in the tumour cells, called TROP2.

Key takeaways

This study is testing a new medicine, SKB264, for advanced solid tumours.
It's for people whose tumours haven't responded to other treatments.
The main goals are to check the medicine's safety and see if it can shrink tumours.
It's an early-stage clinical trial (Phase I-II).
Participants will receive the new medicine and be closely monitored.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, people need to be at least 18 years old. The study is open to both men and women. The most important health requirement is that you have advanced solid tumours that have not responded well to standard treatments that are currently available.

This means that if your cancer has continued to grow despite trying established therapies, you might be suitable. The medical team will carefully review your health records and conduct tests to make sure that taking part in the study is right for you and that you meet all the specific health criteria for patient safety.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a solid tumour that is advanced or has spread?
Has your tumour continued to grow despite trying standard treatments?
Are you able to attend regular hospital appointments and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the new medicine, SKB264. The study will involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. You might also be given other commonly used medicines like paracetamol or treatments for stomach acid (like famotidine, ranitidine, or cimetidine) if needed, under the guidance of the study doctors.

The doctors will closely watch for any changes in your health, including any side effects. You'll have blood samples taken to see how your body handles the medicine and to check your immune system. They will also check if your tumour has specific markers (TROP2 expression). The full duration of your participation, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer some potential benefits, such as access to a new treatment that isn’t widely available yet, which might help your condition. However, there are also potential risks, including side effects from the new medicine, which may be mild or serious, and some effects might not be fully known yet. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care, which is your right as a participant.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Italy

Common questions

What is a 'solid tumour'?

A solid tumour is an abnormal mass of tissue that doesn't include liquid cancers like leukaemias. It's often another way to refer to certain types of cancer.

What does 'unresectable' mean?

Unresectable means that the tumour cannot be fully removed by surgery, either because of its size, location, or because it has spread too widely.

What is a 'Phase I-II study'?

This means it’s an early stage of testing a new medicine in people. Phase I mainly looks at safety and dosage, while Phase II starts to see if the medicine works and also checks for side effects.

Will I definitely get the new medicine SKB264?

Yes, in this specific study, all participants will receive the investigational drug SKB264. There is no placebo group.

What if I experience side effects?

The study team will closely monitor you for any side effects. If you experience any, they will provide the necessary medical care and adjust your treatment if required, ensuring your safety is their top priority.